Environmental Monitoring Performance Qualification In New Facilities: An Industry-Harmonized Approach

Environmental Monitoring Performance Qualification (EMPQ) provides documented proof that your cleanroom environments meet strict predefined standards. The data gathered during EMPQ verifies that your facility's critical systems and procedures—including the HVAC system, cleanroom design, cleaning and disinfection programs, personnel gowning, material transfer protocols, and equipment operation—are all capable of maintaining the necessary microbial and particulate quality limits.

BioPhorum's paper offers a thorough guide to EMPQ for new facilities, drawing on industry best practices and insights from subject matter experts. It covers key aspects such as:

• Prerequisites for EMPQ
• Establishing appropriate alert and action limits
• Defining clear acceptance criteria

Performing an EMPQ is a vital part of your overall contamination control strategy for every production facility. It's a Good Manufacturing Practice (GMP) requirement to qualify cleanrooms throughout the facility's lifecycle. Furthermore, any planned changes that could impact product quality must be carefully assessed, including their potential effect on the cleanroom's qualification status.